dockets: FDA-2026-P-6538

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id agency_id title docket_type last_modified object_id rin dkabstract category subtype keywords program short_title effective_date organization attrs_raw attr_source
FDA-2026-P-6538 FDA Requests that the FDA determine whether Namenda (Memantine Hydrochloride) 5 mg and 10 mg Tablets, NDA#021487 has been voluntarily withdrawn from sale for safety or efficacy reasons. Nonrulemaking 2026-06-08T19:18:08Z 0b000064b931bdd6         ["CDER", "Newcastle Bioscience", "Citizen Petition", "determine", "whether Namenda Memantine Hydrochloride", "5 mg and 10 mg Tablets", "NDA 021487", "has been voluntarily withdrawn", "from sale for safety or efficacy reasons", "OPEN"] CDER Requests that the FDA determine whether Namenda (Memantine Hydrochloride) 5 mg and 10 mg Tablets, NDA#021487 has been voluntarily withdrawn from sale for safety or efficacy reasons.     {"displayProperties": [{"name": "generic", "label": "Docket Item Code", "tooltip": "An agency specific code that identifies the type of document that established the docket (regulatory action)."}, {"name": "program", "label": "Center", "tooltip": "The agency specific program associated with the docket (regulatory action); equivalents: Docket Item Code, Location."}, {"name": "field2", "label": "Docket Status", "tooltip": "Used to Identity that a Docket's Status is Open or Closed"}, {"name": "shortTitle", "label": "Short Title", "tooltip": "A combination of letters and or numbers assigned to an agency's regulatory action for purposes of brevity."}], "keywords": ["CDER", "Newcastle Bioscience", "Citizen Petition", "determine", "whether Namenda Memantine Hydrochloride", "5 mg and 10 mg Tablets", "NDA 021487", "has been voluntarily withdrawn", "from sale for safety or efficacy reasons", "OPEN"], "modifyDate": "2026-06-08T19:18:08Z", "dkAbstract": null, "agencyId": "FDA", "program": "CDER", "shortTitle": "Requests that the FDA determine whether Namenda (Memantine Hydrochloride) 5 mg and 10 mg Tablets, NDA#021487 has been voluntarily withdrawn from sale for safety or efficacy reasons.", "subType2": null, "title": "Requests that the FDA determine whether Namenda (Memantine Hydrochloride) 5 mg and 10 mg Tablets, NDA#021487 has been voluntarily withdrawn from sale for safety or efficacy reasons.", "generic": "P", "field1": null, "docketType": "Nonrulemaking", "petitionNbr": null, "rin": null, "organization": null, "legacyId": null, "subType": null, "category": null, "field2": "OPEN", "effectiveDate": null, "objectId": "0b000064b931bdd6"} single_get

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